MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HEADLESS PIN DRIVER; INSTRUMENT

Catalog Number 6541-4-809

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Material Integrity Problem (2978); Scratched Material (3020)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2015

Event Type  malfunction  

Event Description

Reused fluted headless pin became stuck on tibial cutting block and staff then broke pin inside triathlon pin driver.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

Review of the device history records indicates the lot was manufactured and accepted into final stock on 22-jan-2014.There have been no other events for the lot referenced.The device was returned with the broken hex end of the headless pin still in place and could not be removed.The event was confirmed.The event was confirmed as the tip of the pin was still in the headless pin driver.However the root cause could not be determined as the events leading to the fracture of the pin could not be replicated with the returned parts.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

Reused fluted headless pin became stuck on tibial cutting block and staff then broke pin inside triathlon pin driver.

• Brand Name: HEADLESS PIN DRIVER
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4671901
• MDR Text Key: 5687903
• Report Number: 0002249697-2015-01119
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-4-809
• Device Lot Number: 17008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR